NCT07324447

Brief Summary

CLINICAL TRIAL ON THE EFFECT OF SUPERVISED PHYSICAL EXERCISE AFTER BARIATRIC SURGERY ON MUSCLE MASS AND BONE DENSITY (OBEFIT STUDY)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
30mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Feb 2026Nov 2028

First Submitted

Initial submission to the registry

September 15, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
25 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

January 8, 2026

Status Verified

December 1, 2025

Enrollment Period

1.8 years

First QC Date

September 15, 2025

Last Update Submit

January 7, 2026

Conditions

Physical ExerciseObesity &Amp;Amp; OverweightBariatric Surgery

Keywords

Obesity SurgeryPhysical exerciseBariatric Surgery

Outcome Measures

Primary Outcomes (1)

  • Differences in muscle mass

    To determine the differences in muscle mass and bone density in patients undergoing bariatric surgery who have undergone a post-operative supervised physical exercise programme and no exercise programme. o To determine the differences in muscle function using the hand grip test.

    12 months

Other Outcomes (1)

  • differences in bone density

    12 months

Study Arms (2)

physical exercise program

ACTIVE COMPARATOR

he primary objective is to try to minimise the loss of muscle mass that occurs in the patient. During the first 4 weeks of training, the objective is to familiarise the patient with the type of training to be carried out. The patient will do an initial block of strength work, followed by a block of cardiovascular work on a cycloergometer (continuous and variable) in the same session. Work will be done in order to progress in volume and intensity. Training sessions of approximately 50-60 minutes will be carried out 2 days a week for 12 months.

Behavioral: physical exercise programme

Standard of care

NO INTERVENTION

They will have all the follow-up provided by the hospital in the same way as the intervention group in addition to the relevant assessments carried out throughout the clinical trial, throughout the study they will be encouraged to have an active lifestyle.

Interventions

physical exercise programmeBEHAVIORAL

patients undergoing bariatric surgery who have undergone a post-operative supervised physical exercise programme and no exercise programme.

physical exercise program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are on the waiting list for bariatric surgery (gastric bypass or sleeve) at the Hospital Universitario Virgen del Rocío in Seville, in addition to:
  • Be 18 years of age or older.
  • Suitable for physical exercise.

You may not qualify if:

  • Body weight greater than 150kg.
  • Distance from the place of residence to the Pablo de Olavide University in Seville greater than 60 km or 45 minutes by car.
  • Having any of the following conditions: lipedema, cancer survivors, metabolic bone diseases, consumption of medication or presence of pathology that affects bone health.
  • Patients undergoing dialysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital virgen del rocio

Seville, Sevilla, 41013, Spain

RECRUITING

Universidad Pablo de Olavide

Seville, Sevilla, 41013, Spain

RECRUITING

MeSH Terms

Conditions

ObesityOverweightMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Central Study Contacts

Isaias Alarcon, MD PhD

CONTACT

+34646357875isaiasalarcon@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator and Coordinator of the Esophagogastric and Bariatric Surgery Unit

Study Record Dates

First Submitted

September 15, 2025

First Posted

January 7, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

November 1, 2028

Last Updated

January 8, 2026

Record last verified: 2025-12

Locations

ES(2)